Using SystemCHANGE™ to Enhance Medication Adherence in Older Adult Stroke Survivors
2019年8月19日 更新者:Cynthia Russell、University of Missouri, Kansas City
Randomized Controlled Pilot Study of a SystemCHANGE™ Medication Adherence Intervention in Older Adult Stroke Survivors
This study evaluated the feasibility and acceptability of using a SystemCHANGE intervention in older adult stroke survivors to improve medication adherence.
Half the participants will receive the SystemCHANGE intervention, while the other half will receive the attention-control education intervention.
研究概览
研究类型
介入性
注册 (实际的)
30
阶段
- 第一阶段早期
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
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Missouri
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Parkville、Missouri、美国、64152
- Jennifer Wessol
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
50年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- age ≥50 years old
- receives post-stroke care with Saint Luke's Neurological Consultants
- prescribed at least 1, once a day, antithrombotic medication
- able to provide informed consent
- able to open an electronic cap
- able to self-administer medications
- has or has access to a telephone
- has no cognitive impairment as determined by a score of 4 or greater on The Six- item Screener (SIS).
Exclusion Criteria:
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学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:SystemCHANGE™
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During the intervention phase, the PI will visit both groups of participants at home at baseline and telephone them three times (day 3 ±2 days and months 1 and 2).
Refer to tables 1 and 2 for intervention details.
Treatment participants will implement SystemCHANGE™ activities related to medication taking with the assistance of the PI while attention-control participants will receive patient education materials on stroke.
Perceived health data will be collected during the intervention phase.
A 1-month maintenance phase follows the intervention phase.
Electronic medication monitoring continues, but no intervention is delivered to either group.
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有源比较器:Attention-Control
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An experienced stroke nurse will deliver the attention control intervention.
Table 3.2 shows the 2-month attention-control intervention.
The stroke materials were developed by the Saint Luke's Marion Bloch Neuroscience Institute and are given to every stroke patient prior to dismissal.
The PI will call participants at day 3 ±2 days, and months 1 and 2 to review chapter(s) from the book and answer questions about it.
Interval, frequency, and setting are all exactly the same for the intervention and control groups.
If the control participant raises questions about medications or medication-taking, PI will refer them to their Neurologist.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Acceptability and feasibility
大体时间:one point in time at the end of the maintenance phase which is 3 months after randomization into groups
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Open ended questionnaire
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one point in time at the end of the maintenance phase which is 3 months after randomization into groups
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Social Support
大体时间:One day at beginning of Intervention phase. Once 1 day at beginning of Maintenance phase.
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The Social Support Appraisals Index (SS-A) is a 23-item self-administered, a self-report scale measuring the degree to which a person feels cared for, respected, and involved with family and friends.
The scale had good reliability and validity (Cronbach α coefficients .90,
.81,
and .84)
(Vaux et al., 1986).
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One day at beginning of Intervention phase. Once 1 day at beginning of Maintenance phase.
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Perceived Health
大体时间:One day at beginning of Intervention phase. Once 1 day at beginning of Maintenance phase.
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Perceived health status will be measured by one question, "How is your health in general?"
Participant select excellent, very good, good, fair, poor, or very poor.
Perceived health status reflects people's overall perception of their health, including both physical and psychological dimensions.
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One day at beginning of Intervention phase. Once 1 day at beginning of Maintenance phase.
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Personal Systems Behaviors
大体时间:One day at beginning of Intervention phase. Once 1 day at beginning of Maintenance phase.
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The Systems Thinking Survey (adapted for patients), a 20-item, 5-point Likert response scale measuring perceptions of personal system behaviors.
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One day at beginning of Intervention phase. Once 1 day at beginning of Maintenance phase.
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Medication Adherence
大体时间:after randomization through end of maintenance phase for a total of 3 months
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MA data will be retrieved from the MEMS®cap which is a medication cap containing a battery and microelectronics that records the date and the time of each cap removal to create a medication "event" ("MEMS® Cap versatile adherence monitoring cap," n.d.).
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after randomization through end of maintenance phase for a total of 3 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Jennifer L. Wessol, BSN、University of Missouri, Kansas City
- 学习椅:Cynthia L. Russell, Ph.D.、Professor
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年11月28日
初级完成 (实际的)
2018年2月6日
研究完成 (实际的)
2018年5月24日
研究注册日期
首次提交
2017年7月5日
首先提交符合 QC 标准的
2017年7月6日
首次发布 (实际的)
2017年7月7日
研究记录更新
最后更新发布 (实际的)
2019年8月21日
上次提交的符合 QC 标准的更新
2019年8月19日
最后验证
2019年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
SystemCHANGE™的临床试验
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Ohio State UniversityNational Institute of Nursing Research (NINR); National Institutes of Health (NIH)完全的
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Case Western Reserve UniversityNational Institutes of Health (NIH); American Heart Association完全的
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Asklepios Kliniken Hamburg GmbHUniversity of Kiel完全的气道管理 | 喉罩气道 | 光纤插管
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London Health Sciences CentreUniversity of Western Ontario, Canada; Synaptive Medical未知脑损伤,慢性 | Cerebellar Cognitive Affective Syndrome | 小脑性缄默症
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Andrew ParrentUniversity of Western Ontario, Canada; Synaptive Medical未知
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Boston Scientific Corporation完全的短暂性脑缺血发作 | 血栓栓塞性中风 | 预防中风美国, 阿根廷, 德国